RecruitingNot ApplicableNCT07104370

Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws

Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial

Sponsor

Semmelweis University

Enrollment

30 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

Edentulous Alveolar Ridge Edentulous Alveolar Ridge Atrophy

Summary

After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation. Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties. The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing. The aim of the study is: * to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used, * compare the microarchitecture of the augmented bone depending on the bone graft material applied, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

over 18 years old
require lateral augmentation for implant rehabilitation

Exclusion Criteria9

Smoking
Pregnancy
Poor oral hygiene
Failure to attend follow-up visits
Therapeutic-dose irradiation to the head and neck region
Local bone tumors, cysts, or inflammatory processes
Decompensated systemic diseases contraindicate surgery
Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
Psychiatric disorders contraindicate implant rehabilitation

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Interventions

PROCEDUREBone augmentation using an autologous bone block

* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap. * In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery. * The block is fixed to the recipient site with two screws. * The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures. * Sutures are removed two weeks postoperatively. * All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In the case of an amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided. * Patients do not wear temporary prostheses during the healing period.

PROCEDUREBone augmentation using freeze-dried allograft block

* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap. * In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments. * The block is fixed to the recipient site with two screws. * The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures. * Sutures are removed two weeks postoperatively. * All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In case of amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided. * Patients do not wear temporary prostheses during the healing period.

DIAGNOSTIC_TESTpreoperative cone beam computed tomography (CBCT)

• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.

DIAGNOSTIC_TESTpost-operative cone beam computed tomography (CBCT)

Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.

PROCEDUREDental implant placement

Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.

DIAGNOSTIC_TESTBone core biopsy

At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.

PROCEDUREFixed dental prosthesis (FDP) fabrication

After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.

DEVICEBone grafting

Freeze-dried bone allograft block